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Not Applicable

Mobile Health Intervention for Young Adult Cancer Survivors (mHealthAYA Trial)

N/A
Recruiting
Led By Carla J Berg, PhD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months (end-of-treatment; eot) and 6-month (follow-up; fu)
Awards & highlights

mHealthAYA Trial Summary

This trial aims to test an 8-week phone & app intervention to promote hope & mitigate life disruption caused by cancer in young adults. It involves formative research & an RCT of the intervention vs. attention control in 150 YA survivors. High impact due to reach & scalability.

Who is the study for?
This trial is for young adults aged 20-39 who have been treated for stages I-IV cancer within the last three years. Participants should not have significant psychological disabilities, must understand English, and need to have a smartphone. They also must be willing to commit to an 8-week study that's delivered remotely.Check my eligibility
What is being tested?
The trial is testing an 8-week phone and app-based intervention designed to boost hope and improve quality of life after cancer treatment. It involves comparing this new method with a control group in a randomized controlled trial among 150 young adult survivors.See study design
What are the potential side effects?
Since the intervention focuses on mental health support through technology, there are no direct medical side effects like you'd expect from medication or surgery. However, participants may experience emotional or psychological responses as they engage with the content.

mHealthAYA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months (end-of-treatment; eot) and 6-month (follow-up; fu)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months (end-of-treatment; eot) and 6-month (follow-up; fu) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Adherence
Retention
Secondary outcome measures
Alcohol use
Cannabis use
Hope, per Snyder's Hope Scale
+5 more

mHealthAYA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
Group II: Attention ControlActive Control1 Intervention
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,574 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,602 Total Patients Enrolled
Carla J Berg, PhDPrincipal InvestigatorGeorge Washington University

Media Library

Empirically Supported Protocol (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT05905250 — N/A
Survivorship Research Study Groups: Attention Control, Intervention
Survivorship Clinical Trial 2023: Empirically Supported Protocol Highlights & Side Effects. Trial Name: NCT05905250 — N/A
Empirically Supported Protocol (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905250 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research project open to me?

"200 participants are being sought for this medical trial, all of whom must be aged between 20 and 39 years old and have survivorship."

Answered by AI

Does this research endeavor restrict eligibility to those aged 50 and below?

"According to the requirements for joining this trial, only those aged between 20 and 39 are eligible."

Answered by AI

What are the overarching aims of this clinical trial?

"This trial will be assessed over a 6-month period with adherence as the main goal. Secondary results include Quality of Life - Patient Reported Outcome Measurement Information System (PROMIS) Global Health scale, Quality of Life - Rand Medical Outcome Study 36-Item Short Form Health Survey (SF-36), and Patient Health Questionnaire - 4 item (PHQ-4): Depression and anxiety symptoms which are all scored on scales from 0 to 100 or 12 respectively."

Answered by AI

Are there still vacancies for volunteers to join this experimental trial?

"According to clinicaltrials.gov, the trial was first posted in September of 2023 and has not been updated since June 14th 2023. Thus, this particular study is currently inactive; however, there are 575 other trials actively recruiting participants now."

Answered by AI
~133 spots leftby Aug 2024